The Hepatitis B Vaccine Booster Response Among the Youth Who Had Completed Neonatal Hepatitis B Vaccines

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00792610
• Collaborator: National Science Council, Taiwan (Other)
• Enrollment: 127
• Location: 1
• Arm: 1
• Duration (Months): 18.1
• Patients Per Site Per Month: 7

Study Details

Study Description

Brief Summary

At the time of the present study, the necessity for booster vaccinations for the prevention of hepatitis B(HB) 15 years post-vaccination in the group of young adults who have become seronegative for HB markers after complete neonatal HB vaccination was in question. A booster vaccination strategy may lead to a significant economic impact on national health care resources, and the costs/benefits must therefore be carefully evaluated. Unfortunately, the data to support such analyses are lacking. Because an increased risk of HB infection is anticipated when adolescents enter into young adulthood through becoming sexual active, breakthrough infections such as fulminant HB might be the main concern instead of the risk of chronic HB carriage. To address this issue, this study aimed to measure the booster responses after HB vaccination in seronegative young adults who had completed neonatal HB vaccines in Taiwan before.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B	Biological: hepatitis B vaccine	N/A

Detailed Description

This cohort study was conducted between October 2007 and Jan 2009. The target population was subjects aged 18-23 years who were born after 1984 when the Taiwanese national HB vaccination program was launched. Their vaccination records must have shown a completed neonatal HB vaccination, and they were seronegative for all three HB viral markers including HBsAg(Hepatitis B surface antigen), anti-HBc(core antibody against Hepatitis B), and anti-HBs(Surface antibody against Hepatitis B) within 2 years of entry into the study and at study entry. They were recruited through a Student's Health Center Clinic referral, Bulletin Board System posts, and Web-broadcast invitation. The neonatal HB vaccination records were verified through linkage to the Taiwan Center for Disease Control databank. Signed informed consent was obtained from all the participants and their parents or guardians. Pregnant females, persons with a previous history of allergy to HB vaccines, or allergy to yeast were excluded. First 3 months are screen phase to recruit college students for assay of hepatitis B viral markers. Seronegative subjects were approached for enrollment into receiving hepatitis B vaccine booster afterwards.

All participants were tested for HB markers at enrollment, even if they had been tested in the previous months, to confirm their status. A questionnaire was completed at enrolment to record sociodemographic factors including age, gender, self reported family history of hepatitis B carriers, self reported blood type, and so on. The participants then received three intramuscular doses of HB vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20 microgram/ml/vial, GlaxoSmithKline, Belgium) at baseline and at the 1st and 6th month follow-up visits. Their anti-HBs status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of HB vaccine. Adverse effects associated with the vaccine were also reported within one week after each Engerix-B injection.

Study Design

• Study Type: Interventional
• Actual Enrollment: 127 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Hepatitis B Vaccine Booster Response Among the Youth Who Had Completed Neonatal Hepatitis B Vaccines
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hepatitis B booster They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.	Biological: hepatitis B vaccine; Recombinant HBsAg, 20mcg/ml/vial (GSK) one vial IM at Day 0, Month 1, month 6 during follow-up, respectively.; Other Names: Engerix-B

Outcome Measures

Primary Outcome Measures

1. Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL) [7 months]

   The anti-HBs(Surface antibody against Hepatitis B) status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of hepatitis B vaccine. And then the seroprotective rate for anti-HBs(numbers of those who had anti-HBs titer higher than 10 mIU/mL/all participants numbers) was calculated respectively.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 23 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. aged 18-23 years

2. the youth born after July 1984 who have received a hepatitis B virus markers checkup within 2 years including HBsAg, core antibody against hepatitis B(anti-HBc), and surface antibody against hepatitis B (anti-HBs) and the results are all negative for these 3 viral markers.

3. Participants should agree to sign inform consent. For younger than 20 years old subjects, one of their parents also help the participate review and sign the inform consent.

4. Participants are willing to receive 3 doses of Hepatitis B vaccines without payment.

5. General condition is in good health judged by the doctor

Exclusion Criteria:

1. Allergy to Hepatitis B vaccines or yeast

2. pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	10051

Sponsors and Collaborators

• National Taiwan University Hospital
• National Science Council, Taiwan

Investigators

• Study Chair: Chyi-Feng Jan, Doctor, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00792610
• Other Study ID Numbers: 200701049M; NSC96-2314-B-0020115
• First Posted: Nov 18, 2008
• Last Update Posted: Oct 6, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: youth; hepatitis B; vaccination; booster; immunity response
• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Hepatitis

Study Results

Participant Flow

Recruitment Details	This cohort study was conducted between October 2007 and Jan 2009. The participants were recruited through a Student's Health Center Clinic referral, Bulletin Board System posts, and Web-broadcast invitation. They received intervention and blood exam in the hospital.
Pre-assignment Detail	Initially, 150 seronegative subjects for the three hepatitis B viral markers (HBsAg, anti-HBs, and anti-HBc) were invited to participate in the study. Among them, five subjects were excluded because of seropositive results upon recheck or drop-out. History of complete neonatal HB vaccination could not be confirmed in 18 cases.

Arm/Group Title	Hepatitis B Booster
Arm/Group Description	They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
Period Title: Overall Study
STARTED	127
Youths	127
COMPLETED	127
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Hepatitis B Booster
Arm/Group Description	They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
Overall Participants	127
Age, Customized (participants) [Number]
< 20 years old	54 42.5%
>= 20 years old	73 57.5%
Sex: Female, Male (Count of Participants)
Female	61 48%
Male	66 52%
Blood type (participants) [Number]
A	28 22%
B	31 24.4%
AB	8 6.3%
O	53 41.7%
unknown	7 5.5%
Body Mass Index(BMI) category (participants) [Number]
BMI< 18.5	21 16.5%
18.5<= BMI < 24	94 74%
BMI >= 24	12 9.4%
Family history of hepatitis B carrier (participants) [Number]
Yes	18 14.2%
NO	71 55.9%
Unknown	38 29.9%

Outcome Measures

1. Primary Outcome

Title	Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL)
Description	The anti-HBs(Surface antibody against Hepatitis B) status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of hepatitis B vaccine. And then the seroprotective rate for anti-HBs(numbers of those who had anti-HBs titer higher than 10 mIU/mL/all participants numbers) was calculated respectively.
Time Frame	7 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hepatitis B Booster
Arm/Group Description	They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
Measure Participants	127
seroprotective rate of HB vaccine at 7-10 days	26 20.5%
seroprotective rate of HB vaccine at one month	96 75.6%
seroprotective rate of HB vaccine at 6 months	120 94.5%
seroprotective rate of HB vaccine at 7 months	126 99.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hepatitis B Booster
	Comments	Chi-square analysis and Fischer's exact test were used for comparing group proportions between seropositive and seronegative participants. GMT and their 95% confidence intervals were also calculated using the software developed by Kirkman, T.W. (18) An ANOVA test was performed to compare the difference of the three groups at one, six and seven months categorized by the anti-HBs titers at 7-10 days after the booster.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	.10
	Confidence Interval	() 95%; .05 to .15
	Parameter Dispersion	Type: Standard Deviation; Value: .05
	Estimation Comments

Adverse Events

Arm/Group Title	Hepatitis B Booster
Arm/Group Description	They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
All Cause Mortality
	Hepatitis B Booster
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Hepatitis B Booster
	Affected / at Risk (%)	# Events
Total	0/127 (0%)
Other (Not Including Serious) Adverse Events
	Hepatitis B Booster
	Affected / at Risk (%)	# Events
Total	0/127 (0%)

Limitations/Caveats

The possible presence of T cell memory among the seronegative patients for HBsAg(+), anti-HBc(+), and anti-HBs(+) could be a concern.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.